||January 29, 2014 – The 38th Meeting of the National Children’s Study Federal Advisory Committee (NCSAC)
||The meeting continued and expanded on previous discussions regarding National Children’s Study (NCS) content.
- refined the NCS Study Content Framework and reviewed the pregnancy visits 1 and 2
||October 28, 2013 – The 37th Meeting of the National Children’s Study Federal Advisory Committee (NCSAC)
||The Committee received an update on the current status of the Vanguard Study and IOM Review and discussed study sampling plans, the conceptual framework for study content and data collection.
- recommended that standard instruments be used where they exist.
- suggested instruments or tools be used that measure hearing and vision as they might provide insight into toxicity.
- recommended processing water samples in a single laboratory is a great idea because it would decrease variability.
||July 23, 2013 – The 36th Meeting of the National Children’s Study Federal Advisory Committee (NCSAC)
||The committee discussed the proposed NCS conceptual framework and content development and received and update on retention data.
- expressed concern about the current lack of public use data.
- discussed the adequacy of the proposed sample size for preconception women
- endorsed including subsequent births of siblings for preconception and early pregnancy assessments
- discussed potential tradeoffs in the use of a flexible core questionnaire.
||February 26, 2013 – The 35th Meeting of the National Children’s Study Federal Advisory Committee (NCSAC)
||The committee reviewed and discussed the Main Study design, a draft protocol outline, and an update on the provider based sampling feasibility study
||NCSAC member summarized that:
- sampling strategy issues need to be resolved. The relative balance of prenatal and perinatal strata depends on the Study’s objectives and resources.
- NCSAC is interested in reviewing future protocol, instruments, questionnaires, scales and outcomes.
- the Study can benefit from using other studies measurements and methods specifically NHANES.
||October 24, 2012 – The 34th Meeting of the National Children’s Study Federal Advisory Committee (NCSAC)
||Meeting discussion and questions focused on the plans for Provider Based Feasibility Study to serve as a bridge between the current Vanguard Study experience and the proposed Main Study design and on how to most effectively use the data from this Study to inform the Main Study in the context of logistics and scalability.
- Establishing a sampling frame that minimizes bias though it cannot be bias free.
- Identifying the prenatal exposure variables that may be precursors of outcomes of interest and conduct power calculations on them as a way to reduce costs.
- Discussion of potential complications of matrix sampling for data analysis.
- Developing a more comprehensive list of environmental measures to prioritize for inclusion in the Main Study.
||July 24, 2012 – The 33rd Meeting of the National Children’s Study Federal Advisory Committee (NCSAC)
||The committee continued to discuss the Main Study Design focusing on provider based recruitment, prenatal and birth cohorts.
||Meeting discussion and questions focused on the provider based recruitment strategy, tradeoffs in sample size based on the timing of enrollment and data collection.
No specific recommendations were proffered by the committee.
||April 24, 2012 – The 32nd Meeting of the National Children’s Study Federal Advisory Committee (NCSAC)
||The committee reviewed and discussed advantages and disadvantages of the proposed Main Study design. Vanguard Study investigators were available for discussions and questions by the NCSAC.
||Discussion points included:
No specific recommendations were proffered by the committee.
- Sampling design options
- Probabilistic compared to convenience samples
- Duration of recruitment and enrollment
- Impact of insurance coverage on health disparities issues and the stability of the participant/provider connection.
||January 24, 2012 – The 31st Meeting of the National Children’s Study Federal Advisory Committee (NCSAC)
||The committee reviewed and discussed the observed recruitment biases in the NCS as well as considerations for definitions of children’s health.
The NCS program office provided the committee a review of the instrument development process.
|Health Measurement Network presented the nascent stages and process for developing definitions of children’s health.
The committee concurred with continuing the work of the Health Measurement Network.
||October 19, 2011 – The 30th Meeting of the National Children’s Study Federal Advisory Committee (NCSAC)
||NCS Vanguard scientists provided the committee with “state of the science” presentations on the Vanguard formative research projects that may inform future directions for the Study.
||The topics included genetics, community engagement, informatics and terminology, recruitment and retention, environmental analysis, and behavioral and social sciences.
||July 20, 2011 – The 29th Meeting of the National Children’s Study Federal Advisory Committee (NCSAC)
||The committee received a presentation on Provider Based Sampling Strategy and reviewed and discussed the Main Study Protocol Concepts.
||NCSAC members were asked to comment on the Provider Based Sampling Strategy:
Comments from the NCSAC members were solicited on the Draft Main Study Protocol. Topics included:
- The geographic eligibility criteria – based on the residence of the woman or the location of the provider?
- Approaches for balancing the demographic profile in spite of provider’s weak responsiveness or refusal
- Solutions for provider withdrawal
- Approaches to enroll women who do not seek prenatal care
- Approaches to provider selection and substitution in areas with too few or too many providers.
- The target enrollment population
- The sampling frame
- The concept of a flexible approach for recruitment as well as an adaptive approach to monitor and adjust recruitment
- Enriching the pool of eligible women who are likely to become pregnant
- Comments on the proposed visit schedule
- Comment on the proposed balance of face to face and remote visits. What factors should be considered if we substitute one for the other
- Comments on a flexible approach to the timing of data collection
||April 19, 2011 – The 28th Meeting of the National Children’s Study Federal Advisory Committee (NCSAC)
||The committee received Principal Investigator presentations on experiences in the Vanguard Study and discussed alternate models for secondary sampling units.
||Highlights of the meeting:
- Principal investigator experiences in the Alternate Recruitment Substudy of the Vanguard Study Hi/Lo recruitment strategy overview
- Update on provider-based recruitment strategy
- Enhanced household-based recruitment strategy
- Study sampling strategy: discussion of sampling alternatives––history and current activity
- A new recruitment strategy for the Study
- Discussion on sampling the population for the Study
||January 26, 2011 – The 27th Meeting of the National Children’s Study Federal Advisory Committee (NCSAC)
||The committee discussed ethical considerations of compensation for participating providers; sharing educational materials with participants and communities and received an update on Vanguard recruitment data and dissemination plans.
||Highlights of the meeting:
- The NCSAC agreed that issues of and data from provider compensation should be further explored.
- The NCSAC is in agreement that further investigation is needed on how to balance participant health education and confounding or biasing data; stakeholders and communities need to be involved in solutions.
- The NCSAC agreed that the new formats for presenting data are much improved and informative about past activities.
- The NCSAC agreed that the reasons for participants’ refusals, withdrawals, and loss of eligibility due to change in pregnancy status and moving should be further explored.
||October 14, 2010 – The 26th Meeting of the National Children’s Study Federal Advisory Committee (NCSAC)
||The committee heard comments from the Director of NIEHS and presentations on the qualification and validation of environmental assessments and considerations for analyte selection. The committee also received an overview of the NCS informatics structure as well as Vanguard team presentations on tools and solutions for data capture.
||Highlights of the meeting:
- Update on Vanguard Study recruitment
- Qualification and validation of environmental assessments: considerations for environmental profiles and panels of analytes as they relate to child growth and development parameters as well as a hierarchy of index analytes.
- Developing the 3rd edition of the American Academy of Pediatric’ Pediatric Environmental Health (Green Book)
- Overview of proposed NIEHS Gulf Long-term Follow-up Study: long-term follow-up of oil spill clean-up workers and volunteers
- NCS Information Management Systems updates: the NCS introduced the concept of facilitated decentralization of the NCS information management systems and the use of open source, non-proprietary data systems to support data collection and management.
||July 21, 2010 – The 25th Meeting of the National Children’s Study Federal Advisory Committee (NCSAC)
||The committee heard presentations on NCS Study Data Update, Real time analysis and reporting findings, Environmental methodologies.
||The NCSAC discussed how to improve efficiencies and maximize benefit to the Study. The possibility of reconstituting the subcommittees to address certain topics and issues, and the process for making formal recommendations was discussed.
||April 27, 2010 – The 24th Meeting of the National Children’s Study Federal Advisory Committee (NCSAC)
||The committee heard presentations on NCS Data Update, Legislative Update pertinent to Pediatric Research and the
NCS Communications Plan.
|The NCSAC discussed several issues and made recommendations to the Study’s Program Office that included:
- Clarifying the roles of the various advisory groups (for example, the NCSAC, the Interagency Coordinating Committee [ICC], and the Independent Study Monitoring and Oversight Committee [iSMOC])
- Structuring the NCSAC meetings to allow for adequate discussion time
- Presenting detailed Study data updates
- Addressing study recruitment challenges
- Focusing on study participant retention at future meetings
- Summarizing the Study’s document translation policy
- Identifying ways in which the NCSAC can publically support the Study.
||January 14, 2010 – The 23rd Meeting of the National Children’s Study Federal Advisory Committee (NCSAC)
- Study update
- Update on Vanguard Study recruitment and visits
- Rationale for additional or alternate recruitment strategies that include Provider-based, Enhanced household enumeration and High-intensity/low-intensity (HiLo)
- Report on data access
- Overview of federated model of institutional review board (IRB) review of the Study
|The Committee supports the piloting of alternate recruitment strategies. Members also:
- Emphasized the importance of collecting placenta data.
- Recommended that the Study evaluate among the births the proportion that completes each data collection element at each of the prescribed collection times.
- Cautioned Study Planners that changing the recruitment approach may change the type of people who are recruited into the Study.
- Recommended an evaluation of the relationship between the interviewer type and the type of incentives on outcomes.
- Recommended that the Study assess patients’ perceptions of influence and feelings of obligation because of a physicians’ referral.
- Recommended that providers should include health education nurses and birthing class leaders.
- Proposed the Study evaluate the inherent bias of the recruiter-based approach
- Emphasized the importance of community engagement while implementing and evaluating the various recruitment strategies.
- Expressed concern with how Study findings are shared with American Indian and Alaska Native populations.
- Supported the Study’s approach to provide equal access to all potential investigators regardless of Study affiliation.